Oral GLP-1R is here!

On May 27, the CDE official website showed that the marketing application of Novo Nordisk Smegglutide tablets was officially accepted by the State Food and Drug Administrati.

Two Phase III clinical trials (PIONEER11/12) of semaglutide tablets compared with placebo or sitagliptin in the treatment of patients with type 2 diabetes have been completed, according to the Chinese Clinical Trials Databa.

Semaglutide is a long-acting glucagon-like peptide-1 receptor (GLP-1R) agoni.

Comparison of T2DM Treatment Drugs

The hypoglycemic effect of oral semaglutide was confirmed in 10 PIONEER clinical trials involving a total of 9543 patients with type 2 diabet.

Remark:

PIONEER 6 is a cardiovascular safety study, PIONEER 9 and PIONEER 10 are Japan regional studies

PIONEER 1, Oral Semaglutide (3, 7, 14mg) vs Placebo in Adult T2D Patients Controlled by Exercise and Diet Only

PIONEER 2, adult patients with T2D, oral semaglutide 14mg vs empagliflozin 25mg

PIONEER 3, adult patients with T2D, oral semaglutide (3, 7, 14mg) vs sitagliptin 100mg

PIONEER 4, Adult T2D, Oral Semaglutide 14mg vs Liraglutide 8mg vs Placebo

PIONEER 5, Adult T2D with Moderate Renal Impairment, Oral Semaglutide 14mg vs Placebo

PIONEER 7, Adult T2D Patients, Oral Semaglutide Adjusted Dose vs Sitagliptin 100mg

PIONEER 8, long-term insulin-receiving T2D patients, oral semaglutide (3, 7, 14 mg) vs placebo

PIONEER11 and PIONEER 12 are international multi-center clinical trials based on Chinese populati.

Semaglutide tablets were first approved by the FDA on September 20, 2019, for a combination of diet and exercise to improve blood sugar control in patients with type 2 diabetes, marketed as Rybels.

Currently, a total of 8 GLP-1R agonist hypoglycemic drugs (excluding compound preparations) are listed worldwide, and the global market size in 2021 will be approximately US$15 billion, mainly controlled by Novo Nordisk and Eli Lil.

In China, 8 GLP-1Rs have been approved for marketing, including short-acting formulations benaglutide, exenatide and lixisenatide that require subcutaneous injection 1 to 3 times a day; subcutaneous injection once a day Injectable long-acting formulations liraglutide; weekly subcutaneous injections of ultra-long-acting formulations include semaglutide, dulaglutide, weekly exenatide and macrogolloxenati.

Domestic marketed GLP-1RA drugs

Oral dosage forms get rid of the inconvenience and psychological torture caused by injection, and at the same time have lower blood sugar and weight loss than mainstream drugs such as liraglutide, empagliflozin (SGLT-2) and sitagliptin (DPP-